CEL-SCI (CVM) - 2025 Q2 - Quarterly Report

Clinical Trial Results - CEL-SCI's investigational therapy Multikine demonstrated a 73% survival rate at 5 years compared to 45% in the control group, resulting in a hazard ratio of 0.35[95] - The Phase III study showed a 28.6% absolute 5-year overall survival benefit for Multikine patients versus control (p=0.0015)[101] - Multikine was administered to approximately 740 patients across multiple clinical trials, with no significant safety issues reported[102] - The Phase III trial observed a 22% pre-surgical downstaging rate in Multikine patients compared to 13% in the control group[105] - Multikine treatment resulted in a 5-year risk of death reduced to 27% from 55% in the control group[111] - The hazard ratio of 0.35 indicates that deaths occurred in the Multikine group about one-third as frequently as in the control group[117] - Multikine-treated patients in the target population had a 73% 5-year survival rate compared to 45% in the control group, with a hazard ratio of 0.35[135] Regulatory Strategy - CEL-SCI plans to seek accelerated approval for Multikine based on the confirmatory study results without waiting for another clinical trial[125] - CEL-SCI's regulatory strategy includes a 212-patient randomized controlled confirmatory registration study focusing on the target population[126] - The confirmatory registration study will focus on 212 patients with newly diagnosed locally advanced primary head and neck cancer, aiming for full enrollment in about 15 months[135] Financial Performance - The company incurred a net operating loss of approximately $13.3 million for the six months ended March 31, 2025, compared to a loss of $13.6 million for the same period in 2024[141] - Research and development expenses for the six months ended March 31, 2025, totaled $8.4 million, a decrease of 6% from $9.0 million in the prior year[144] - General and administrative expenses increased by approximately $0.3 million, or 6%, for the six months ended March 31, 2025, compared to the same period in 2024[146] - The company’s cash decreased by approximately $2.8 million during the six months ended March 31, 2025, primarily due to regular operational funding[138] - The company has financed its operations through equity securities, convertible notes, loans, and research grants, and anticipates continued net operating losses[134] - The company’s research and development expenses for Multikine were approximately $8.4 million for the six months ended March 31, 2025[150] - The company is dependent on raising capital to support its operations and has substantial doubt about its ability to continue as a going concern[137] Market Overview - The global cancer immunotherapy market is projected to reach USD $196.45 billion by 2030, with a CAGR of 7.2%[90] Market Risk - The Company does not believe that it has any significant exposure to market risk[158]